1. Field of the Invention
This invention relates, generally, to indwelling medical devices. More specifically, it relates to an improvement in the tube and retention member coupling to maintain the external retention member's desired location along the tube.
2. Brief Description of the Prior Art
Percutaneous (placed through the skin) enteral feeding tubes are extremely prevalent in the medical field for providing patients who have a functioning gastrointestinal with a means for receiving nutrients when they are unable to eat through their mouths. Percutaneous enteral feeding tubes are used when normal oral intake of nutrients is insufficient (e.g., anorexia, burn victims, cystic fibrosis) and/or unsafe due to anatomic or neurologic dysfunction (e.g., cancer, stroke, head trauma, GI dysfunction/obstruction, neuromuscular disease, etc. . . . ). It is estimated that greater than 200,000 gastrostomy (stomach) tubes are placed each year in the US alone (See Roche V: Percutaneous endoscopic gastrostomy. Clinical care of PEG tubes in older adults. Geriatrics 2003; 58(11):22-26, 28-29.)
A common potential issue associated with percutaneous enteral feeding tubes is securing the tube in place. Accidental dislodgment is one of the most frequent causes of avoidable cost and consternation related to percutaneous enteral feeding tubes. For example, accidental gastrostomy dislodgement is an estimated $23 Million problem in the U.S. (See Rosenberger, L H, Newhook, T, Schirmer, B, et al: Late accidental dislodgement of a percutaneous endoscopic gastrostomy tube: an underestimated burden on patients and the health care system. Surg. Endosc. 25(10): p. 3307-11, 2011.) In order to prevent dislodgement, a combination of an external retention member or external bolster (i.e. a disc, or linear bolster) is often used to keep internally retained feeding tubes (by a balloon or bumper) in place. After placement of the percutaneous feeding tube, the internal retention device (i.e. balloon, or bumper) is pulled against the stomach wall, then the external retention member or external bolster is pushed down to the skin. The only thing that keeps the retention member or external bolster in place is friction around the tube. When the retention member or external bolster remains close to the skin, there is no significant motion of the internal balloon or bumper, and the risk of pericatheter leakage is decreased. When the retention member or external bolster slides back, the gastrostomy tube is no longer held in place and there is an increasing “back and forth” motion of the balloon. This “back and forth” motion leads to an increased risk of complications, including peritube leakage, skin excoriation, infection, bleeding, inadequate feeding, and tube replacement/upsizing. The enteral secretions leaking around the tube cause inflammation; skin excoriation; infection; widening of the tract, thereby causing more leakage ultimately leading to tube dislodgment; exchange/upsizing of the tube; possible need for antibiotic therapy; or even emergency department visits and hospital admissions. In addition, the forward dislodgement of the tube may lead to gastric or intestinal obstruction, with severe abdominal pain and inability to get needed nutrients.
Currently, the methods used to keep the retention member or external bolster in place, vary between addition of a plastic ring, tightening a 0-silk suture or tying a zip-tie around the neck of the retention member or external bolster. However, these methods restrict the lumen of the tube, which increases the risk of tube occlusion. The external retention mechanism for most percutaneous enteral feeding tubes, whether it is a gastrostomy (G) (tube in stomach), gastrojejunostomy (GJ) (tube in small bowel through stomach) or jejunostomy tube (J) (tube in small bowel) is a similar retention member that is pushed down to the skin, and has the same mechanism of action. Friction with the tube is the means by which the retention member is held in place.
Currently, the available designs and methods for securing the location of a retention member or external bolster at a desired location along an indwelling tube lack the ability to secure them in a simplistic manner without increasing the risk of tube occlusion. Available designs also secure the location of the retention member or external bolster to the tube through internal interaction with them.
U.S. Pat. No. 5,092,850 to Buma teaches a more complex design using saw teeth on both the tube and the retention member and a compression element to secure the location of the retention member. Essentially this is a screw like securing means, which can be more expensive to manufacture. The saw teeth design can also cause increased discomfort when contacting the patient's skin.
U.S. Pat. No. 5,484,420 to Russo teaches securing the location of a retention member along a tube using a twist lock or zip tie like fastening means. This design increases the risk of tube occlusion, which is a major problem with the current state of the art.
U.S. Pat Application No. 20040186461 to DiMatteo teaches a catheter with an adjustable cuff. The locatable cuff is adapted to mate with the external mounting projection on the tube, but the cuff is not capable of sliding along the tube to another projection. The cuff must be removed from the tube to be relocated and contains fastening means to secure both halves of the cuff around the projection.
Accordingly, what is needed is a simple indwelling tube and retention member design that prevents the retention member from being dislodged and moving to an undesirable location along the tube while also not increasing the risk of tube occlusion. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.
All referenced publications are incorporated herein by reference in their entirety. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein, is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.
The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.
In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.